Getinge Flow-e Anesthesia System — Class I medical device recall Z-0961-2023
Ongoing recall by Getinge Usa Sales Inc, reported 2023-02-01, distributed nationwide. Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If g
| Recall number | Z-0961-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-01-26 |
| Reported by FDA | 2023-02-01 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07325710010457 |
| Serial numbers | 50012-50197 |
| Model numbers | 07325710010457, 6887900 |
Product
Getinge Flow-e Anesthesia System, Part No. 6887900
Reason for recall
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0961-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.